OsteoporosisNCT02436356
New Tools for Assessing Fracture Risk
A study testing Osteoprobe-Reference Point Indentation (RPI), Dual-energy X-ray absorptiometry (DXA) Scans and MRI in people with Osteoporosis and Fracture Risk Assessment, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The goal of this study is to determine whether two new, non-X-ray techniques can discriminate between high-energy fractures of normal bone (trauma) and low-energy fractures (fragility) of osteoporotic bone. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Fracture Risk Assessment
- What is being tested?
- Osteoprobe-Reference Point Indentation (RPI), Dual-energy X-ray absorptiometry (DXA) Scans and MRI
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2015to 8 Nov 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who are 18 years of age or older. This age range accounts for 60% of all distal radius fractures seen at Vanderbilt University Medical Center.
- Patients who have sustained a low or high energy distal radius fracture that involves the metaphysis and requires open reduction internal fixation using volar plating.
- English speaking due to feasibility of employing study personnel to deliver and assess study intervention.
- Patients who are 18 years of age or older.
- Patients who have no history of fracture or family history of pathologic fracture
- English speaking due to feasibility of employing study personnel to deliver and assess study intervention.
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- Patients who are 18 years of age or older. This age range accounts for 60% of all distal radius fractures seen at Vanderbilt University Medical Center.
- Patients who have sustained a low or high energy distal radius fracture that requires nonoperative treatment
- English speaking due to feasibility of employing study personnel to deliver and assess study intervention.
Who cannot join
- Patients who have known risk factors of pathologic fractures (e.g. bone metastasis)
- Patients who have or are receiving treatment for osteoporosis (e.g. bisphosphonate) lasted longer than 5 years
- Patients who have Type 1 diabetes
- Patients who have other bone disease (e.g., osteogenesis imperfecta, Paget's disease, thyroid disease, Vitamin D deficiency, hyperparathyroidism)
- Patients that have a history of cancer, abnormal serum calcium, or chronic steroid use
- Patients that would not be able to have a DXA scan (weight >350lbs, hardware in hips, patients that have lap band device)
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- Patients who are pregnant or who think they may be pregnant
- Patients that have a medical contraindication to MRI (if patients are undergoing a study MRI)
- Patients who have concurrent, bilateral upper extremity fractures where hardware or casting may affect study scan measurements
- Patients who have distal radial shaft fractures
- Exclusion criteria 1-5 are included because the goal of the study is to demonstrate whether new bone measurements differentiate normal bone from fragile bone. These exclusion criteria eliminate confounding factors that affect fracture resistance of bone in ways that are independent of osteoporosis. Exclusion criteria 6-8 are practical since DXA/MRI scans cannot accommodate all people.
- Inclusion/exclusion criteria for patients with no fracture (Arm 2)
- Number of patients in Arm#2= 40 patients
- Patients who are taking medication to treat osteoporosis (e.g. bisphosphonate)
- Patients who have or are receiving treatment for osteoporosis (e.g. bisphosphonate) lasted longer than 5 years
- Patients who have Type 1 diabetes
- Patients who have other bone disease (e.g., osteogenesis imperfecta, Paget's disease, thyroid disease, Vitamin D deficiency, hyperparathyroidism).
- Patients that have a history of cancer, abnormal serum calcium, or chronic steroid use.
- Patients that would not be able to have a DXA scan (weight >350lbs, hardware in hips, patients that have lap band device)
- Patients who are pregnant or who think they may be pregnant.
- Patients that have a medical contraindication to MRI.
- Exclusion criteria 1-5 are included because the goal of the study is to demonstrate whether new bone measurements differentiate normal bone from fragile bone. These exclusion criteria eliminate confounding factors that affect fracture resistance of bone in ways that are independent of osteoporosis. Exclusion criteria 6- 8 are practical since DXA/MRI scans cannot accommodate all people.
- Inclusion/exclusion criteria for patients with a high-energy or fragility fracture requiring nonoperative treatment (Arm 3)
- Number of patients in Arm#3= up to 10 patients
- Patients who have known risk factors of pathologic fractures (e.g. bone metastasis)
- Patients who have or are receiving treatment for osteoporosis (e.g. bisphosphonate) lasted longer than 5 years
- Patients who have Type 1 diabetes
- Patients who have other bone disease (e.g., osteogenesis imperfecta, Paget's disease, thyroid disease, Vitamin D deficiency, hyperparathyroidism)
- Patients that have a history of cancer, abnormal serum calcium, or chronic steroid use
- Patients that would not be able to have a DXA scan (weight >350lbs, hardware in hips, patients that have lap band device)
- Patients who are pregnant or who think they may be pregnant
- Patients that have a medical contraindication to MRI (if patients are undergoing a study MRI)
- Patients who have concurrent, bilateral upper extremity fractures where hardware or casting may affect study scan measurements
- Exclusion criteria 1-5 are included because the goal of the study is to demonstrate whether new bone measurements differentiate normal bone from fragile bone. These exclusion criteria eliminate confounding factors that affect fracture resistance of bone in ways that are independent of osteoporosis. Exclusion criteria 6-8 are practical since DXA/MRI scans cannot accommodate all people.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt Univeristy Medical Center
Nashville, Tennessee, 37232
About this study
The goal of this study is to determine whether two new, non-X-ray techniques can discriminate between high-energy fractures of normal bone (trauma) and low-energy fractures (fragility) of osteoporotic bone. The current gold-standard for assessing fracture risk areal bone mineral density (aBMD) by dual energy X-ray absorptiometry (DXA) is not particularly effective at identifying individuals who are at risk of suffering a fracture. Yet, there is a growing population of diabetics and elderly individuals prone to fractures. In effect, the age-related and diabetes-related increase in fracture risk is independent of a person's aBMD. These findings stress the urgency in developing diagnostic tools that can improve fracture risk prediction so that patients can be treated with the appropriate anti-fracture therapies.
- Conditions
- Osteoporosis, Fracture Risk Assessment
- Being tested
- Osteoprobe-Reference Point Indentation (RPI), Dual-energy X-ray absorptiometry (DXA) Scans, MRI
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteoprobe-Reference Point Indentation (RPI)Device
Diagnostic tool used for bone indentation to measure the ability of the tissue to resist microindentation (bone mineral strength).
Dual-energy X-ray absorptiometry (DXA) ScansRadiation
Assessment of Fracture Risk
MRIRadiation
Determines bound water and pore water of bone.
| Study group | Role | What they receive |
|---|---|---|
| Distal Radius Fracture Operative Group | Active comparator | Fracture group patients will undergo DXA and MRI scans, along with Osteoprobe indentation. Receives: Device: Osteoprobe-Reference Point Indentation (RPI); Radiation: Dual-energy X-ray absorptiometry (DXA) Scans; Radiation: MRI |
| Healthy Volunteers (Non Fracture Group) | Active comparator | Healthy volunteers will undergo DXA and MRI scans. Receives: Radiation: Dual-energy X-ray absorptiometry (DXA) Scans; Radiation: MRI |
| Distal Radius Fracture Non-operative Group | Active comparator | Fracture group patients will undergo DXA and MRI scans, but will not undergo Osteoprobe indentation. Receives: Radiation: Dual-energy X-ray absorptiometry (DXA) Scans; Radiation: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Osteoprobe Measurements
Bone Material Strength index (BMSi)
By engaging the bone at 10 N and then delivering a single impact force of ~40 N, the OsteoProbe records the maximum penetration depth of conical-spherical tip into cortical bone. This indentation distance increase (IDI) is indexed to the IDI acquired from a reference material immediately after the bone IDI measurements, such that the OsteoProbe-based measurement known as bone material strength index (BMSi) is 100 times IDI of reference material divided by IDI of the patient's bone. A lower BMSi measurement is the result of a higher indentation distance into the bone. For statistical analysis, we used the mean of the 10 BMSi measurements per case.
Measured: Within a week before or after surgery to repair distal radius fracture
MRI Scan Measurements
Bound Water Fraction
Measured: Within a week before or after surgery to repair distal radius fracture
MRI Scan Measurements
Pore Water Fraction
Measured: Within a week before or after surgery to repair distal radius fracture
DXA Scan Measurements
Bone Mineral Density
Measured: Within a week before or after surgery to repair distal radius fracture
DXA Scan Measurements
Bone Mineral Content
Measured: Within a week before or after surgery to repair distal radius fracture
DXA Scan Measurements
A T-score is the number of standard deviations (SD) below (negative value) or above (positive value) the mean BMD (bone mineral density) for a healthy population. A person with T-score below -2.5 is considered to have osteoporosis.
Measured: Within a week before or after surgery to repair distal radius fracture
Secondary outcomes (2)
Patient-reported Measurements
DASH (Disabilities of the Arm, Shoulder, and Hand) is a 30-item self-report questionnaire designed to assess musculoskeletal disorders of the upper limbs. The score ranges from 0 (no disability) to 100 (most severe disability). A higher scores indicate a greater level of disability and severity, whereas, lower scores indicate a lower level of disability.
Measured: Baseline/One-Time Completion and Post-op/-treatment: 3, 6, and 12 weeks
Patient-reported Measurements
PRWE (Patient-rated wrist evaluation) is a 15-item survey designed to measure wrist pain and disability in activities of daily living. The PRWE consists of a pain subscale and a function subscale. The pain subscale contains 5 items, each rated 0 (no pain) to 10 (worst pain ever). The pain subscale is calculated by adding all 5 item scores together (minimum score: 0, maximum score: 50). A lower score indicates a lower pain level. The function subscale contains 10 items, each rated 0 (no difficulty) to 10 (unable to do). The function subscale is calculated by adding all 10 item scores together and dividing by 2 (minimum score: 0, maximum score: 100). A lower score indicates a lower disability level. The total PRWE score is calculated by adding the pain and function subscales together. The total PRWE score ranges from 0 (best score) to 100 (worst score). The lower the score the better the outcome.
Measured: Baseline and Post-op/-treatment: 3, 6, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study start30 Jun 2015
- Primary completion23 May 2018
- Study completion8 Nov 2018
Why it stopped: FDA determined study device is significant risk. Study will not seek IDE.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ActiveLife Scientific, National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Jeffry Nyman, Vanderbilt University Medical Center
- Investigators
- Jeffry S Nyman, PhD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02436356
- Sponsor's protocol ID
- 141125
- Other IDs
- UL1TR000445
- Status last verified
- Oct 2020
- First submitted
- 24 Apr 2015
- Last updated
- 2 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No current plant to share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Tools for Assessing Fracture Risk
- ClinicalTrials.gov ID
- NCT02436356
- Acronym / sponsor ID
- 141125
- Conditions
- Osteoporosis, Fracture Risk Assessment
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: FDA determined study device is significant risk. Study will not seek IDE.
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- ActiveLife Scientific, National Center for Advancing Translational Sciences (NCATS)
- Study start
- 30 Jun 2015 (actual)
- Primary completion
- 23 May 2018 (actual)
- Study completion
- 8 Nov 2018 (actual)
- First posted
- 6 May 2015 (estimated)
- Results
- Posted 12 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to determine whether two new, non-X-ray techniques can discriminate between high-energy fractures of normal bone (trauma) and low-energy fractures (fragility) of osteoporotic bone. The current gold-standard for assessing fracture risk areal bone mineral density (aBMD) by dual energy X-ray absorptiometry (DXA) is not particularly effective at identifying individuals who are at risk of suffering a fracture. Yet, there is a growing population of diabetics and elderly individuals prone to fractures. In effect, the age-related and diabetes-related increase in fracture risk is independent of a person's aBMD. These findings stress the urgency in developing diagnostic tools that can improve fracture risk prediction so that patients can be treated with the appropriate anti-fracture therapies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Distal Radius Fracture Operative Group | Active comparator | Device: Osteoprobe-Reference Point Indentation (RPI), Radiation: Dual-energy X-ray absorptiometry (DXA) Scans, Radiation: MRIFracture group patients will undergo DXA and MRI scans, along with Osteoprobe indentation. |
| Healthy Volunteers (Non Fracture Group) | Active comparator | Radiation: Dual-energy X-ray absorptiometry (DXA) Scans, Radiation: MRIHealthy volunteers will undergo DXA and MRI scans. |
| Distal Radius Fracture Non-operative Group | Active comparator | Radiation: Dual-energy X-ray absorptiometry (DXA) Scans, Radiation: MRIFracture group patients will undergo DXA and MRI scans, but will not undergo Osteoprobe indentation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients who are 18 years of age or older. This age range accounts for 60% of all distal radius fractures seen at Vanderbilt University Medical Center.
- Patients who have sustained a low or high energy distal radius fracture that involves the metaphysis and requires open reduction internal fixation using volar plating.
- English speaking due to feasibility of employing study personnel to deliver and assess study intervention.
- Patients who are 18 years of age or older.
- Patients who have no history of fracture or family history of pathologic fracture
Key exclusion criteria (34 listed)
- Patients who have known risk factors of pathologic fractures (e.g. bone metastasis)
- Patients who have or are receiving treatment for osteoporosis (e.g. bisphosphonate) lasted longer than 5 years
- Patients who have Type 1 diabetes
- Patients who have other bone disease (e.g., osteogenesis imperfecta, Paget's disease, thyroid disease, Vitamin D deficiency, hyperparathyroidism)
- Patients that have a history of cancer, abnormal serum calcium, or chronic steroid use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteoprobe-Reference Point Indentation (RPI)Diagnostic tool used for bone indentation to measure the ability of the tissue to resist microindentation (bone mineral strength). | Device | Distal Radius Fracture Operative Group |
| Dual-energy X-ray absorptiometry (DXA) ScansAssessment of Fracture Risk | Radiation | Distal Radius Fracture Non-operative Group, Distal Radius Fracture Operative Group, Healthy Volunteers (Non Fracture Group) |
| MRIDetermines bound water and pore water of bone. | Radiation | Distal Radius Fracture Non-operative Group, Distal Radius Fracture Operative Group, Healthy Volunteers (Non Fracture Group) |
Primary outcome
Osteoprobe Measurements
Time frame: Within a week before or after surgery to repair distal radius fracture
Bone Material Strength index (BMSi) By engaging the bone at 10 N and then delivering a single impact force of ~40 N, the OsteoProbe records the maximum penetration depth of conical-spherical tip into cortical bone. This indentation distance increase (IDI) is indexed to the IDI acquired from a reference material immediately after the bone IDI measurements, such that the OsteoProbe-based measurement known as bone material strength index (BMSi) is 100 times IDI of reference material divided by IDI of the patient's bone. A lower BMSi measurement is the result of a higher indentation distance into the bone. For statistical analysis, we used the mean of the 10 BMSi measurements per case.
MRI Scan Measurements
Time frame: Within a week before or after surgery to repair distal radius fracture
Bound Water Fraction
MRI Scan Measurements
Time frame: Within a week before or after surgery to repair distal radius fracture
Pore Water Fraction
DXA Scan Measurements
Time frame: Within a week before or after surgery to repair distal radius fracture
Bone Mineral Density
DXA Scan Measurements
Time frame: Within a week before or after surgery to repair distal radius fracture
Bone Mineral Content
DXA Scan Measurements
Time frame: Within a week before or after surgery to repair distal radius fracture
A T-score is the number of standard deviations (SD) below (negative value) or above (positive value) the mean BMD (bone mineral density) for a healthy population. A person with T-score below -2.5 is considered to have osteoporosis.
2 secondary outcomes
Patient-reported Measurements
Time frame: Baseline/One-Time Completion and Post-op/-treatment: 3, 6, and 12 weeks
Patient-reported Measurements
Time frame: Baseline and Post-op/-treatment: 3, 6, and 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No current plant to share individual participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffry S Nyman, PhD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteoprobe-Reference Point Indentation (RPI), Dual-energy X-ray absorptiometry (DXA) Scans and MRI in people with Osteoporosis and Fracture Risk Assessment, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Osteoprobe Measurements (time frame: Within a week before or after surgery to repair distal radius fracture). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2020.